BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSCILLATING AND SAGITTAL BLADE

    MDR report key: 2466128 · Received February 9, 2012

    Report

    Report Number
    9616696-2012-00030
    Event Type
    Malfunction
    Date Received
    February 9, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 13, 2012
    Manufacturer
    STRYKER IRELAND LTD.
    Product Code
    DWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE BLADE SUBJECT TO THIS INVESTIGATION WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; IT WAS DISCARDED. LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED TO PERMIT FURTHER INVESTIGATION. THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE, THE BLADE BROKE AT THE MOUNT. IT WAS ALSO REPORTED THAT THERE WAS NO PT INJURY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSCILLATING AND SAGITTAL BLADE DWH STRYKER IRELAND LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK